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Astellas Pharma Australia
Astellas Pharma Australia has
announced that the indication for Xtandi
(enzalutamide) has been extended by
the Therapeutic Goods Administration
(TGA) to include the treatment of
patients with metastatic castration-
resistant prostate cancer (mCRPC)
following the failure of androgen
deprivation therapy (ADT) in whom
chemotherapy is not yet indicated.
Prostate cancer that has extended
beyond the prostate into the
surrounding tissue, into other organs or
into distant parts of the body, is called
advanced prostate cancer.
Up to 40%
of men with prostate cancer develop
metastatic disease and a large number
of men with advanced prostate cancer
eventually develop resistance to ADT,
and progress to mCRPC.
previously been approved by the TGA
for use in mCRPC – but only where
the patient had previously received
docetaxel (i.e. chemotherapy).
Associate Professor Anthony Lowe,
CEO of Prostate Cancer Foundation
of Australia, said, ‘The prospect of
having access to medicines that can
be introduced prior to chemotherapy
should be a major focus for the future.
This approval is an important milestone
for patients and their clinicians, but
the main issue is to look at how access
to new, evidence-based medicines
and/or indications can be improved
to further help men with advanced
1. 1. Cancer Council Australia 2009. APCC Advanced prostate
cancer: a guide for men and their families. P043 pro. At:
Guide_2009_BOOKMARKS.pdf [Accessed Dec 2015]
Bayer and Janssen
Bayer and its development partner
Janssen Pharmaceuticals have released
the results from two real world studies
– the noninterventional XALIA study
in patients with deep-vein thrombosis
(DVT) and a study in patients with
cancer-associated thrombosis (CAT) –
with XALIA showing low rates of major
bleeding (1.23%/year) and recurrent
venous thromboembolism (VTE) (2.21%/
year) with Xarelto (rivaroxaban).
Results from the two studies were
presented at the 2015 American Society
of Haematology Annual Meeting, and
XALIA findings were also simultaneously
published in The Lancet Haematology.
XALIA Principal Investigator Professor
Alexander GG Turpie, McMaster
University and Hamilton Health
Sciences in Hamilton, Ontario, Canada
said: ‘It is important we understand
the effectiveness and safety profile
of available treatment options for
potentially life-threatening blood
clots in real world patient populations.
‘ The real world insights from XALIA
confirm the positive benefit-risk profile
of rivaroxaban for the treatment of deep
vein thrombosis that was established
in the Phase III EINSTEIN DVT study,
endorsing that these pivotal data for
rivaroxaban can be translated to the
patients who physicians typically see in
everyday clinical practice.’
1. Agena, W et al. Safety and effectiveness of oral rivaroxaban
versus standard anticoagulation for the treatment
of symptomatic deep-vein thrombosis (XALIA): an
international, prospective, non-interventional study. Lancet
Haematol. Published online December 7, 2015. At: http://
2. Ageno W. Rivaroxaban or Standard Anticoagulant
Treatment for Deep Vein Thrombosis. Oral Presentation at
ASH 2015. 7 Dec 2015.
3. Soff GA. Safe and Effective Use of Rivaroxaban for Treatment
of Cancer-Associated Venous Thromboembolic Disease: A
Prospective Cohort Study. Oral Presentation at ASH 2015.
7 Dec 2015.
4. Prins MH, Lensing AWA, Bauersachs R, et al, on behalf
of the EINSTEIN Investigators. Oral rivaroxaban versus
standard therapy for the treatment of symptomatic venous
thromboembolism: a pooled analysis of the EINSTEIN-DVT
and PE randomized studies. Thromb J. 2013;11(1):21.
New product for the
treatment of travellers’
XIFAXAN® 200 mg film-coated tablets
(Rifaximin 200 mg) is a new oral
antibiotic specifically approved for the
treatment of travellers’ diarrhoea.
XIFAXAN is indicated for the treatment
of patients (12 years or older) with
travellers’ diarrhoea caused by non-
invasive strains of Escherichia coli.
It will be available in Australia from
Ordering codes XIFAXAN 200MG TAB 9.
API: 11434. Sigma: 208397. Symbion:
XIFAXAN 200 mg is a Prescription Only
It is not PBS listed.
Please review the Product Information
before prescribing. Product
Information is available from Norgine
Pty Limited (please call 1800 636 000 to
Norgine Pty Limited (ABN 78 005 022
882), 3/14 Rodborough Road, Frenchs
Forest NSW 2086.
Product under licence from Alfa
Wassermann S.p.A. XIFAXAN is a
registered trademark of the Alfa
Wassermann group of companies,
licensed to the Norgine group of
1. XIFAXAN 200 mg Product Information, 26 May 2015
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